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Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00238953
First received: October 12, 2005
Last updated: February 21, 2017
Last verified: February 2017

October 12, 2005
February 21, 2017
February 2005
June 2006   (Final data collection date for primary outcome measure)
  • 6 Month evaluation
  • patient and graft survival
  • acute rejection (suspected or biopsy confirmed)
  • graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate),
  • infections, adverse events, serious adverse events.
Not Provided
Complete list of historical versions of study NCT00238953 on ClinicalTrials.gov Archive Site
Influence of parameters: demography, medical conditions, complications post transplantation on main clinical outcomes. 6 month evaluation
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Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
A Prospective, Open Label Protocol to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
Renal Transplantation
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Experimental: EC MPS
Intervention: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Wyzgał J, Niemczyk M, Ziółkowski J, Durlik M, Wiecek A. Results of a 6-month, multicenter, open-label, prospective study concerning efficacy and safety of mycophenolate sodium in de novo kidney transplant recipients. Transplant Proc. 2007 Nov;39(9):2730-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2006
June 2006   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Male and females aged 18 to 75
  • Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression

Exclusion criteria:

  • Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
  • Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).
  • Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline.

Other inclusion/exclusion criteria may apply

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00238953
CERL080APL01
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Novartis
Novartis
Not Provided
Study Director: Novartis Novartis
Novartis
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP